Details for New Drug Application (NDA): 075772
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The generic ingredient in KETOROLAC TROMETHAMINE is ketorolac tromethamine; phenylephrine hydrochloride. There are eighteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the ketorolac tromethamine; phenylephrine hydrochloride profile page.
Summary for 075772
Tradename: | KETOROLAC TROMETHAMINE |
Applicant: | Hikma |
Ingredient: | ketorolac tromethamine |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 075772
Mechanism of Action | Cyclooxygenase Inhibitors |
Medical Subject Heading (MeSH) Categories for 075772
Suppliers and Packaging for NDA: 075772
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
KETOROLAC TROMETHAMINE | ketorolac tromethamine | INJECTABLE;INJECTION | 075772 | ANDA | Hikma Pharmaceuticals USA Inc. | 0641-6041 | 0641-6041-25 | 25 VIAL in 1 CARTON (0641-6041-25) / 1 mL in 1 VIAL (0641-6041-01) |
KETOROLAC TROMETHAMINE | ketorolac tromethamine | INJECTABLE;INJECTION | 075772 | ANDA | Hikma Pharmaceuticals USA Inc. | 0641-6042 | 0641-6042-25 | 25 VIAL in 1 CARTON (0641-6042-25) / 1 mL in 1 VIAL (0641-6042-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 15MG/ML | ||||
Approval Date: | Jul 21, 2004 | TE: | AP | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 30MG/ML | ||||
Approval Date: | Jul 21, 2004 | TE: | AP | RLD: | No |
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